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Symptom Assessment (symptom + assessment)
Selected AbstractsSafety of efalizumab in adults with chronic moderate to severe plaque psoriasis: A phase IIIb, randomized, controlled trialINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 5 2006Kim A. Papp MD Background, To provide safety data for efalizumab, a recombinant humanized monoclonal IgG1 antibody, in adults with chronic plaque psoriasis. Methods, A 12-week, Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled trial. At 58 study sites in the USA and Canada, 686 patients with moderate to severe chronic plaque psoriasis received an initial conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) followed by either 11 weekly doses of efalizumab 1 mg/kg SC or matching placebo. Main outcome measures were safety and tolerability outcomes (primary) and efficacy outcomes (secondary). Results, During 12 weeks of therapy with efalizumab or placebo, the incidence of clinical adverse events was 82.2% and 72.9%, respectively; the incidence of serious adverse events was 1.8% and 3.4%, respectively; and the incidence of nonserious adverse events leading to withdrawal was 1.8% and 1.7%, respectively. In the efalizumab group, there were no clinically significant changes in vital signs or laboratory parameters and no evidence of end-organ toxicities. A significantly higher proportion of patients receiving efalizumab than those receiving placebo achieved , 75% improvement in the Psoriasis Area and Severity Index (PASI) (P < 0.001), , 50% improvement in PASI (P < 0.001), and a static Physician's Global Assessment rating of Minimal or Clear (P < 0.001). The mean improvement in the Psoriasis Symptom Assessment was significantly greater in the efalizumab group (P < 0.001). Conclusions, Efalizumab treatment SC for 12 weeks was safe, well tolerated, and effective in patients with moderate to severe chronic plaque psoriasis. [source] Short-term symptom and quality-of-life comparison between laparoscopic Nissen and Toupet fundoplicationsDISEASES OF THE ESOPHAGUS, Issue 1 2009R. Radajewski SUMMARY Laparoscopic antireflux surgery is an established method of treatment of gastroesophageal reflux disease (GERD). This study evaluates the efficacy of Nissen versus Toupet fundoplication in alleviating the symptoms of GERD and compares the two techniques for the development of post-fundoplication symptoms and quality of life (QOL) at 12 months post-surgery. In this prospective consecutive cohort study, 94 patients presenting for laparoscopic antireflux surgery underwent either laparoscopic Nissen fundoplication (LN) (n = 51) from February 2002 to February 2004 or a laparoscopic Toupet fundoplication (LT) (n = 43) from March 2004 to March 2006, performed by a single surgeon (G. S. S.). Symptom assessment, a QOL scoring instrument, and dysphagia questionnaires were applied pre- and postoperatively. At 12 months post-surgery, patient satisfaction levels in both groups were high and similar (LT: 98%, LN: 90%; P = 0.21). The proportion of patients reporting improvement in their reflux symptoms was similar in both groups (LT: 95%, LN: 92%; P = 0.68), as were post-fundoplication symptoms (LT: 30%, LN: 37%; P = 0.52). Six patients in the Nissen group required dilatation for dysphagia compared with one in the Toupet group (LT: 2%, LN: 12%; P = 0.12). One patient in the Nissen group required conversion to Toupet for persistent dysphagia (P = 0.54). In this series, overall symptom improvement, QOL, and patient satisfaction were equivalent 12 months following laparoscopic Nissen or Toupet fundoplication. There was no difference in post-fundoplication symptoms between the two groups, although there was a trend toward a higher dilatation requirement and reoperation after Nissen fundoplication. [source] Long-term frontal sinus patency after endoscopic frontal sinusotomy,THE LARYNGOSCOPE, Issue 6 2009Yvonne Chan MD Abstract Background: The frontal recess is the drainage pathway that connects the frontal sinus to the anterior ethmoid sinus. Mechanical obstruction is the primary cause of chronic frontal sinusitis with or without a secondary inflammatory process. Eosinophilic inflammation is one of the underlying causes for chronic rhinosinusitis. Objectives/Hyphothesis: To evaluate long-term frontal sinus patency after endoscopic frontal sinusotomy in chronic rhinosinusitis patients and to assess the effect of eosinophilic inflammation on frontal sinus patency. Study Design: Retrospective chart review. Symptom assessment and archived endoscopic photographs were prospectively collected on patients who underwent frontal sinusotomy between 7-1-1999 and 12-31-2000. Subjective symptom improvements were evaluated using the SNOT-20 = 20-item Sino-Nasal Outcome Test. Objective findings of endoscopic frontal sinus patency were documented by archived digital photography. Results: A total of 161 patients with 294 frontal sinuses who underwent endoscopic frontal sinus surgery in the 18 months had an average follow-up of 45.9 months. The patient population was divided into two groups: 58 patients had eosinophilic CRS (ECRS), and 103 patients had CRS without eosinophils (non-ECRS). The mean follow-up for patients with ECRS is 61.6 months and 37.0 months for non-ECRS patients. The non-ECRS patients had a documented endoscopic frontal sinus patency of 90%, and the ECRS patients had an endoscopic frontal sinus patency of 85%. The overall frontal ostium patency rate for all patients was 88.0%. Conclusions: Long-term endoscopic confirmation of frontal ostium patency demonstrates that endoscopic frontal sinusotomy can yield high quality, durable results. There was no significant difference in patency results between ECRS and non-ECRS patients. Laryngoscope, 2009 [source] A placebo-controlled trial of mirtazapine for the management of methamphetamine withdrawalDRUG AND ALCOHOL REVIEW, Issue 3 2008CHRISTOPHER C. CRUICKSHANK Abstract Introduction and Aims. As an antidepressant with sedative and anxiolytic properties, mirtazapine may be an appropriate pharmacotherapy for methamphetamine withdrawal. This study sought to examine whether mirtazapine improves retention and alleviates methamphetamine withdrawal symptoms in an out-patient setting. Design and Methods. An out-patient double-blind, randomised placebo-controlled trial of mirtazapine for the treatment of methamphetamine withdrawal was conducted (15 mg nocte for 2 days, 30 mg nocte for 12 days). Both groups were offered narrative therapy counselling. Measures recorded on days 0, 3, 7, 14 and 35 included: treatment retention, Amphetamine Cessation Symptoms Assessment, the Athens Insomnia Scale, the Brief Symptom Inventory, the Depression,Anxiety,Stress Scale (DASS), Severity of Dependence scale and the Opiate Treatment Index Drug Use subscale. Results. Thirty-one participants were recruited (18 placebo, 13 mirtazapine) and 52% completed the 2-week medication phase. No significant differences between the mirtazapine and placebo groups in retention, or any symptom measure were observed, except greater DASS,anxiety and longer sleep duration were measured at baseline among the mirtazapine group. Discussion and Conclusions. Results suggest that mirtazapine does not facilitate retention or recruitment in out-patient methamphetamine withdrawal treatment, although recruitment may have been insufficient to identify a significant treatment effect. The potential role of narrative therapy for methamphetamine dependent patients deserves further exploration. [source] Validation of a brief symptom questionnaire (ReQuest in Practice) for patients with gastro-oesophageal reflux diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2008G. RUBIN Summary Background, A clinical need exists for a means of assessing symptom control in patients with gastro-oesophageal reflux disease. The ReQuest questionnaire has been extensively validated for symptom assessment in both erosive and non-erosive gastro-oesophageal reflux disease but was designed for research purposes. We derived a shorter version (ReQuest in Practice) that would be more convenient for clinical practice. Aim, To validate ReQuest in Practice in patients suffering from gastro-oesophageal reflux disease. Methods, Multicentre, non-interventional, crossover comparison. Patients completed ReQuest in Practice followed by ReQuest or vice versa. Before and after a planned endoscopy, patients completed the health-related quality of life questionnaire GERDyzer. Internal consistency and the Intraclass Correlation Coefficient were calculated. Construct validity was evaluated by correlation with ReQuest and GERDyzer. Results, There was high internal consistency of ReQuest in Practice (Cronbach's alpha: 0.9) and a high Intraclass Correlation Coefficient of 0.99. The measurement error of ReQuest in Practice was 4.1. High correlation between ReQuest in Practice and ReQuest (Spearman correlation coefficient: 0.9) and GERDyzer (Spearman correlation coefficient: 0.8) demonstrated construct validity. Conclusions, ReQuest in Practice was proven to be valid and reliable. Its close correlation with ReQuest makes it a promising tool to guide the clinical management of patients across the full spectrum of both erosive and non-erosive gastro-oesophageal reflux disease. [source] Do we need a new gastro-oesophageal reflux disease questionnaire?ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2004V. Stanghellini Summary Background :,Gastro-oesophageal reflux disease (GERD) is highly prevalent in Western countries. Because the majority of patients do not present with endoscopic abnormalities, the assessment of the symptom severity and quality of life, and their response to treatment, has become increasingly important. Self-assessed symptom questionnaires are now key instruments in clinicaltrials. Aim :,To evaluate the validity of available GERD measurement tools. Methods :,An ideal GERD symptom assessment instrument, suitable as a primary end-point for clinical trials, should possess the following characteristics: (i) be sensitive in patients with GERD; (ii) cover the frequency and intensity of typical and atypical GERD symptoms; (iii) be multidimensional (cover all symptom dimensions); (iv) have proven psychometric properties (validity, reliability and responsiveness); (v) be practical and economical; (vi) be self-assessed; (vii) use ,word pictures' which are easy to understand for patients; (viii) respond rapidly to changes (responsiveness over short time intervals); (ix) be used daily to assess changes during and after therapy; and (x) be valid in different languages for international use. Results :,A literature review revealed five scales that met some of the above characteristics, but did not fulfil all criteria. Conclusion :,There is a need for a new evaluative tool for the assessment of GERD symptoms and their response to therapy. [source] Association of the status of interstitial cells of Cajal and electrogastrogram parameters, gastric emptying and symptoms in patients with gastroparesisNEUROGASTROENTEROLOGY & MOTILITY, Issue 1 2010Z. Lin Abstract, Our goal was to investigate associations between the status of interstitial cells of Cajal (ICC) and electrogastrogram (EGG) parameters, gastric emptying and symptoms in a large cohort of patients with gastroparesis. Forty-one patients with refractory gastroparesis who were referred for gastric electrical stimulation (GES) underwent full thickness gastric (antrum) biopsy during the surgery to place the GES device. The biopsy samples were stained with c-kit and scored for the presence of ICC based on criteria obtained from 10 controls. All patients underwent EGG recordings, a 4-h standardized scintigraphic gastric emptying study and symptom assessment prior to the surgery. Based on antral biopsy, 15 patients (36%) had almost no ICC (ICC, group) and 26 patients had adequate cell numbers (ICC+ group). EGG recordings in the ICC, group displayed significantly less normal slow waves than in the ICC+ group both in the fasting and fed states. Tachygastria in the ICC, group was significantly more than in the ICC+ group both in the fasting (32 ± 8%vs 11 ± 2%) and fed states (27 ± 9%vs 12 ± 2%). There was no statistical difference in gastric emptying, symptom severity of gastroparesis, aetiology, age and gender between the two groups. Severely depleted ICC occurs in up to 36% of gastroparetic patients and significantly correlates with an abnormal EGG. Severely depleted ICC does not correlate with the severity of gastroparesis as assessed by gastric emptying or symptom status but did result in a poorer symptomatic response to GES. These data suggest that the EGG may have a role for predicting ICC status during clinical evaluation of gastroparetic patients. [source] Pathophysiology as a basis for understanding symptom complexes and therapeutic targetsNEUROGASTROENTEROLOGY & MOTILITY, Issue 2 2004M. Camilleri Abstract, Sensorimotor disorders of the stomach, small intestine and colon have a limited repertoire of clinical manifestations, and there is the potential for more than one mechanism to lead to symptoms. In many recent clinical trial programs of novel agents in neurogastroenterology, the emphasis has been primarily on symptom assessment of broad groups of patients identified by the Rome criteria. Drugs of potential value have fallen by the wayside with this approach. We propose the current paradigm is partly to blame; physiological testing should provide the basis for identifying more homogeneous populations and therapeutic targets within functional bowel disease, and this applies to the upper and lower gut. Here we summarize the evidence that certain biomarkers can, in a limited fashion, be used to predict the success of an experimental medicine in common disorders of gastrointestinal function, including the irritable bowel syndrome and functional dyspepsia. Although the current evidence is limited and is most convincingly demonstrated with examples of transit measurements (for loperamide, alosetron, tegaserod and piboserod), we perceive this paradigm that studies using validated and responsive biomarkers have an important role to play in drug development. [source] Classifying subgroups of patients with symptoms of acute coronary syndromes: A cluster analysisRESEARCH IN NURSING & HEALTH, Issue 5 2010Holli A. DeVon Abstract The purpose of the study was to identify subgroups of patients presenting with acute coronary syndromes based on symptom clusters. Two hundred fifty-six patients completed a symptom assessment in their hospital rooms. Latent class cluster analysis and analysis of variance were used to classify subgroups of patients according to selected clinical characteristics. Four subgroups were identified and labeled as Heavy Symptom Burden, Chest Pain Only, Sweating and Weak, and Short of Breath and Weak (model fit ,2 [130,891, n,=,256],=,867.5, p,=,1.00). The largest group of patients experienced classic symptoms of chest pain and shortness of breath but not sweating. Younger patients were more likely to cluster in the Heavy Symptom Burden group (F,=,5.08, p,=,.002). Interpretation of the clinical significance of these groupings requires further study. © 2010 Wiley Periodicals, Inc. Res Nurs Health 33:386,397, 2010 [source] Current and future use of the mannitol bronchial challenge in everyday clinical practiceTHE CLINICAL RESPIRATORY JOURNAL, Issue 4 2009Celeste Porsbjerg Abstract Objectives:, Asthma is a disease associated with inflammation, airway hyperresponsiveness (AHR) and airflow limitation. Clinical diagnosis and management of asthma often relies on assessment of lung function and symptom control, but these factors do not always correlate well with underlying inflammation. Bronchial challenge tests (BCTs) assess AHR, and can be used to assist in the diagnosis and management of asthma. Data Source:, Data presented at the symposium ,Use of inhaled mannitol for assessing airways disease' organised by the Allied Respiratory Professionals Assembly (9) of the European Respiratory Society (ERS) at the ERS Congress, Berlin 2008. Results:, Indirect challenge tests such as exercise testing, hypertonic saline or adenosine 5,-monophosphate (AMP) are more specific though less sensitive than direct challenge tests (such as methacholine) for identifying patients with active asthma. Indirect BCTs may be used to diagnose exercise-induced bronchoconstriction or AHR consistent with active asthma, to evaluate AHR that will respond to treatment with anti-inflammatory drugs and to determine the effectiveness and optimal dosing of such therapy. An ideal indirect challenge test should be standardised and reproducible, and the test result should correlate with the degree of airway inflammation. The mannitol BCT provides a standardised and rapid point-of-need test to identify currently active asthma, and is clinically useful in the identification of patients with asthma who are likely to benefit from inhaled corticosteroid therapy. Conclusion:, In the future, mannitol BCT may be added to lung function and symptom assessment to aid in the everyday management of asthma. Please cite this paper as: Porsbjerg C, Backer V, Joos G, Kerstjens HAM and Rodriguez-Roisin R. Current and future use of the mannitol bronchial challenge in everyday clinical practice. The Clinical Respiratory Journal 2009; 3: 189,197. [source] Combined antegrade and retrograde endoscopic retroperitoneal bypass of ureteric strictures: a modification of the ,rendezvous' procedureBJU INTERNATIONAL, Issue 7 2010David R. Yates Study Type , Therapy (case series) Level of Evidence 4 OBJECTIVE To evaluate our experience of treating complicated iatrogenic ureteric strictures with a combined antegrade and retrograde endoscopic retroperitoneal bypass technique, a modification of the so-called ,rendezvous' procedure. PATIENTS AND METHODS Seven patients presented to our institution between 2004 and 2008 after developing a complicated iatrogenic ureteric stricture, impassable with solitary antegrade or retrograde stenting techniques. In most cases there was a significant loss of ureteric continuity, with some strictures of up to 10,12 cm. After initial temporizing management with a percutaneous nephrostomy, each patient had a radiological ,rendezvous' procedure to insert a JJ stent and restore ureteric continuity. After 6 months, the JJ stents were removed and the patients evaluated by symptom assessment, serial measurements of serum creatinine and diuretic renography (F-15 mercaptoacetyl triglycine). RESULTS All seven ,rendezvous' procedures were successful and a ureteric stent was inserted across or around the stricture in all cases. Five of seven patients whose follow-up was >6 months had their stent removed successfully. At a median follow-up of 21 months, all patients are alive and none has required subsequent surgery. Six of the seven patients presented with significant symptoms and they are all currently symptom-free, which we consider to be a successful clinical outcome. No patient has developed significant renal impairment (estimated glomerular filtration rate (<30 mL/min) but we could only confirm successful unequivocal renographic drainage in one patient. CONCLUSION Combining antegrade radiological and retrograde endourological techniques, it is possible to restore ureteric continuity with a JJ stent, even in situations with extensive loss of the ureteric lumen. This reduces the need for morbid open surgical repair and offers a long-term solution to patients who might otherwise be consigned to less favourable conservative measures. [source] Is the conservative management of chronic retention in men ever justified?BJU INTERNATIONAL, Issue 6 2003T.S. Bates OBJECTIVE To assess the outcome of men presenting with lower urinary tract symptoms (LUTS) associated with large postvoid residual urine volumes (PVR). PATIENTS AND METHODS The study included men presenting with LUTS and a PVR of >,250 mL who, because of significant comorbidity, a low symptom score or patient request, were managed conservatively and prospectively, and were followed with symptom assessment, serum creatinine levels, flow rates and renal ultrasonography. Patients were actively managed if there was a history of previous outflow tract surgery, prostate cancer, urethral strictures, neuropathy, elevated creatinine or hydronephrosis. In all, 93 men (mean age 70 years, range 40,84) with a median (range) PVR of 363 mL (250,700) were included in the study and followed for 5 (3,10) years. At presentation, the median maximum flow rate was 10.2 (3,30) mL/s and the voided volume 316 (89,714) mL. RESULTS The measured PVR remained stable in 47 (51%), reduced in 27 (29%) and increased in 19 (20%) patients; 31 patients (33%) went on to transurethral resection of the prostate after a median of 30 (10,120) months, because of serum creatinine elevation (two), acute retention (seven), increasing PVR (eight) and worsening symptoms (14). Of 31 patients 25 were available for evaluation after surgery; their median PVR was 159 (0,1000) mL, flow rate 18.4 (4,37) mL/s and voided volume 321 (90,653) mL. Symptoms were improved in all but five men. There was no difference in initial flow rate, voided volume or PVR between those who developed complications or went on to surgery and those who did not. Urinary tract infections (UTIs) occurred in five patients and two developed bladder stones. CONCLUSIONS Complications such as renal failure, acute retention and UTIs are uncommon in men with large, chronic PVRs. Conservative management for this group of patients is reasonable but outpatient review is prudent. There were no factors that could be used to predict those patients who eventually required surgery. [source] One-year prevalence of subthreshold and threshold DSM-IV generalized anxiety disorder in a nationally representative sampleDEPRESSION AND ANXIETY, Issue 2 2001Robin M. Carter B.A. Abstract Several studies of representative populations have reported prevalence rates of DSM-III and DSM-III-R generalized anxiety disorder (GAD); however, no community study has examined the effect of the stricter DSM-IV criteria on prevalence estimates and patterns of comorbidity. Furthermore, past studies based on "lifetime" symptom assessments might have led to upper-bound 1-year and point prevalence estimates. Data is presented from a national representative sample study of 4,181 adults in Germany, 18,65 years old, who were interviewed for DSM-IV disorders with the 12-month version of the Munich-Composite International Diagnostic Interview. The prevalence rate of strictly defined, 12-month threshold DSM-IV GAD was estimated to be 1.5%; however, 3.6% of respondents presented with at least subthreshold syndromes of GAD during the past 12 months. Higher rates of worrying and GAD were found in women (worrying 10%, GAD 2.7%) and in older respondents (worrying 9.3%, TAD 2.2%). Taking into account a wider scope of diagnoses than previous studies, a high degree of comorbidity in GAD cases was confirmed: 59.1% of all 12-month GAD cases fulfilled criteria for major depression, and 55.9% fulfilled criteria for any other anxiety disorder. In conclusion, prevalence and comorbidity rates found for DSM-IV GAD are not substantially different from rates reported for DSM-III-R GAD. The minor differences in our findings compared to previous reports are more likely attributable to differences in study methodology rather than changes in diagnostic criteria for DSM-IV. Depression and Anxiety 13:78,88, 2001. © 2001 Wiley-Liss, Inc. [source] Prevalence and longitudinal stability of negative symptoms in healthy participantsINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 12 2009Lindsay C. Emmerson Abstract Objective Although negative symptoms are prominent in older patients with schizophrenia, it is unknown whether this pattern is prevalent in healthy participants. The objective of this study was to evaluate whether negative symptoms are present in healthy populations and to determine whether they are linked to illness-related processes or normal aging. Methods A systemic review of 26 studies that have administered negative symptom assessments to healthy participants was conducted. In addition, 213 (age,>,40,years old) healthy participants completed PANSS and SANS ratings at both baseline and 1-year follow-up. One-hundred participants also completed ratings after 3 years. Results Across all reviewed studies, negative symptoms were absent in the majority of participants. Comparable results were found in the current study's large longitudinal evaluation with middle-aged to older adults. Conclusions Taken together, the data suggest that healthy volunteers do not suffer from prominent negative symptoms. This finding is consistent with the hypothesis that the greater prevalence and severity of negative symptoms in older patients is not related to normal aging but to illness-related processes. Copyright © 2009 John Wiley & Sons, Ltd. [source] | ||||||||||||||||||||||